New drug explored for advanced ALS: small trial shows promise?
NCT ID NCT00415519
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tested a drug called MCI-186 in 25 people with advanced ALS (severity grade III) to see if it could slow the disease. Participants received either the drug or a placebo daily through an IV for 24 weeks. The main goal was to measure changes in daily function and safety, but the results were exploratory and not conclusive.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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25 people
The number who actually took part.
- Started
-
Dec 2006
- Finished
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Jul 2008
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House. * Patients who cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life. * Patients whose progress of the condition during 12 weeks before administration meet other requirements. Exclusion Criteria: * Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, sever heart disease, sever renal disease and so on, or they need to be administered antibiotics to infection. * Patients who complain the difficulty in breathing caused by deteriorating the respiratory function. * Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone. * Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. * Patients who have been administered other investigational products within 12 weeks before consent, or who are participating in other clinical trials at present. * In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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